NEW YORK – The US Food and Drug Administration has granted Kyverna Therapeutics permission to begin clinical trials of its autologous anti-CD19 CAR T-cell therapy candidate KYV-101 in a new indication, treatment-refractory stiff-person syndrome, the biopharmaceutical company said Thursday.
This marks the eighth investigational new drug (IND) application for KYV-101, Kyverna's lead candidate, that has been cleared by the FDA.
The new IND clearance from the FDA enables Kyverna to kick off an open-label Phase II clinical trial, dubbed KYSA-8. Within the clinical trial, investigators will test KYV-101 in patients with stiff-person syndrome, a rare and progressive neurological autoimmune disorder that can lead to debilitating muscle stiffness.
KYV-101 is already being clinically tested in other B cell-driven autoimmune indications including lupus nephritis, systemic sclerosis, and myasthenia gravis. Earlier this week, researchers published results of a first-in-disease use of KYV-101 in a patient with stiff-person syndrome as part of a named-patient treatment option in Germany in the Proceedings of the National Academy of Sciences, reporting clinical improvements such as reduced leg stiffness and increased walking distance.
To date, 30 patients have been treated with KYV-101 across 15 rheumatological and neurological autoimmune conditions, and investigators have observed promising safety results and drug-free remission in most patients, Emeryville, California-based Kyverna reported at the European Alliance of Associations for Rheumatology Congress in Vienna last week.